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Chronic Lymphocytic LeukemiaPhase 2NCT01627054

A Phase II Study of AT7519M, a CDK Inhibitor, in Patients With Relapsed and/or Refractory Chronic Lymphocytic Leukemia

A Phase 2 study testing AT7519M in people with Chronic Lymphocytic Leukemia, run by NCIC Clinical Trials Group at 3 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to find out what effects a new drug AT7519M has on chronic lymphocytic leukemia. Read more about this study

Who is it for?
Ages 18 months and older
Conditions the study is for
Chronic Lymphocytic Leukemia
What is being tested?
AT7519M
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
3 sitesCanada
Study dates
27 Aug 2012to 13 Feb 2015
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 months and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Previously documented CLL as defined by the 2008 International Workshop on Chronic Lymphocytic Leukemia guidelines [Hallek 2008(a)], that is recurrent or relapsed after previous therapy and that requires treatment.
  • Patients must have a life expectancy of at least 12 weeks.
  • Age ≥ 18 years.
  • ECOG performance status of 0, 1 or 2
  • Measurable disease criteria to assess response. Patients must have at least ONE of:
  • Absolute lymphocyte count ≥ 10 x 10^9/L OR At least one pathologically enlarged lymph node (≥ 2 x 2 cm) by CT scan
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  • Previous Therapy Patients must have received at least one, and may have received up to three prior systemic treatment regimens (single agent or combination therapy), there is no limit on number of prior regimens.
  • Systemic Therapy:
  • Patients must have received at least one prior systemic treatment regimen (single agent or combination therapy). There is no limit on number of prior regimens.
  • Patients must be ≥ 4 weeks since last dose of systemic therapy (including investigational). Exceptions to the 4-week interval since last treatment are possible if prior therapy is non-myelosuppressive or if any treatment-related myelosuppression has resolved.
  • Rationale:
  • Based on a review of recently published phase II trials of CDK inhibitors in relapsed and refractory CLL, there does not appear to be sufficient grounds to restrict the number of previous cycles of systemic chemotherapy. The IND193 investigators do not predict that this change will affect either the safety or efficacy outcomes of the study drug.
  • Not permitted:
  • Radioactive Monoclonal Antibody Therapy
  • Prior treatment with AT7519M or another CDK inhibitor
  • Previous allogeneic stem cell transplant (Note: autologous stem cell transplant is permitted)
  • Radiation:
  • Patients may have had radiation, provided a minimum of 21 days has elapsed prior to enrollment. (Exceptions may be made however, for low dose, palliative radiotherapy Patients must have recovered from any acute toxic effects from radiation prior to registration.
  • Surgery:
  • Previous surgery is permitted provided that wound healing has occurred and at least 14 days have elapsed if surgery was major.
  • Laboratory Requirements: (must be done within 7 days prior to registration) Hematology = Absolute neutrophils (ANC) ≥ 1.0 x 10^9/L Platelets = ≥ 75 x 10^9/L (exception: if ITP secondary to CLL, allow 50 x 10^9/L) Chemistry = Creatinine clearance* ≥ 50 mL/min Creatine Phosphokinase = (CK or CPK) ≤ UNL Bilirubin = ≤ UNL AST and ALT = ≤ 2.5 x UNL Potassium, Calcium, Magnesium Within normal limits
  • Patient consent must be obtained according to local Institutional and/or University Human Experimentation Committee requirements. It will be the responsibility of the local participating investigators to obtain the necessary local clearance, and to indicate in writing to the NCIC CTG Study Coordinator that such clearance has been obtained, before the trial can commence in that centre. Because of differing requirements, a standard consent form for the trial will not be provided but a sample form is provided as a separate attachment. A copy of the initial REB approval and approved consent form must be sent to the central office. The patient must sign the consent form prior to registration. Please note that the consent form for this study must contain a statement which gives permission for the NCIC CTG and monitoring agencies to review patient records.
  • Patients must be accessible for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating centre. This implies there must be reasonable geographical limits (for example: 1 ½ hour's driving distance) placed on patients being considered for this trial. Investigators must assure themselves the patients registered on this trial will be available for complete documentation of the treatment, response assessment, adverse events, and follow-up.
  • In accordance with NCIC CTG policy, protocol treatment is to begin within 5 working days of patient registration.

Who cannot join

  • Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, other in situ cancers or other invasive malignancies curatively treated with no evidence of disease for ≥ 5 years.
  • Patients with known CNS involvement by CLL. Tests to investigate CNS involvement are required only if clinically indicated (i.e. disease suspected on basis of symptoms or other findings).
  • Patients with clinically suspected or proven progression to high grade lymphoma (Richter's transformation) or myelodysplasia.
  • Patients with known hypersensitivity to the study drug or its components.
  • The following are exclusions for enrolment on the study:
  • Pregnant or lactating women. (N.B.: All women of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to registration).
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  • Men and women of childbearing potential who do not agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of the study participation. (Should a woman become pregnant or suspect she is pregnant, or should a man father a child, while participating in this study, she/he should inform the treating physician immediately.)
  • Serious illness or medical condition which would not permit the patient to be managed according to the protocol, including, but not limited to:
  • history of significant neurologic or psychiatric disorder (e.g. uncontrolled psychotic disorders) which would impair the ability to obtain consent or limit compliance with study requirements;
  • active uncontrolled or serious infection (viral, bacterial or fungal);
  • pulmonary disease requiring oxygen;
  • known HIV infection or other immune deficiency disorders (except for CLL);
  • other medical conditions that might be aggravated by study treatment
  • Patients with pre-existing cardiovascular conditions and/or symptomatic cardiac dysfunction as follows:
  • Significant cardiac event (including heart failure or ischemia) within 3 months of entry or any cardiac disease that, in the opinion of the investigator, increases risk for ventricular arrhythmia
  • Any family or personal history of ventricular arrhythmia, which was symptomatic or required treatment (CTC grade 3). This includes: multifocal PVCs, bigeminy, trigeminy, ventricular tachycardia)
  • Uncontrolled hypertension (systolic blood pressure of 150 mmHg or higher or diastolic blood pressure of 95 mmHg or higher)
  • A previous history of drug induced QTc prolongation (defined as a QTc interval equal to or greater than 500 msec) or other significant ECG abnormalities
  • Congenital long QT syndrome
  • QT and QTc, unmeasurable or > 460 msec on screening ECG
  • Left ventricular ejection fraction (LVEF) of less than the institution's lower limit of normal (LLN) measured by MUGA or echocardiogram
  • Patients who are currently receiving treatment with agents with a known risk of Torsades de Pointes. (see http://torsades.org [list #1]). However, patients may be enrolled on study if treatment with such agents is stopped ≥ 7 days prior to first dose of AT7519M.
  • Patients with pre-existing peripheral neuropathy (sensory and/or pain) > grade 2.
  • Patients with uncontrolled auto-immune hemolytic anemia (AIHA) and/or auto-immune thrombocytopenia (ITP) who require active treatment.

Trial locations and contacts

3 sites in 1 country.

Canada3 sites

  • Juravinski Cancer Centre at Hamilton Health Sciences

    Hamilton, Ontario, L8V 5C2

  • Univ. Health Network-Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

About this study

The purpose of this study is to find out what effects a new drug AT7519M has on chronic lymphocytic leukemia.

Read the detailed description

This research is being done because AT7519M has been shown to shrink tumours in animals, has been studied in a few people and seems promising, but it is not clear if it can offer better results than standard treatment.

Being tested
AT7519M
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AT7519MDrug

    Dose: 27 mg/m2, IV injection, 1 hour infusion Schedule: 27 mg/m2/day twice weekly x 2 weeks every 3 weeks (days 1, 4, 8 and 11)

Study groups in NCT01627054
Study groupRoleWhat they receive
AT7519MExperimentalNot described
Receives: Drug: AT7519M

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate

    Efficacy (as assessed by objective response rate) of AT7519M when given as a 1 hour intravenous infusion twice weekly for two out of three weeks in patients with relapsed and/or refractory chronic lymphocytic leukemia.

    Measured: 24 months

Secondary outcomes (3)

  1. Toxicity severity

    Measured: 24 months

  2. Time to progression

    Measured: 24 months

  3. Response duration

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2012 (estimated)
  2. Study start27 Aug 2012
  3. Primary completion21 Mar 2014
  4. Study completion13 Feb 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01627054
Sponsor's protocol ID
I193
Status last verified
Mar 2020
First submitted
21 Jun 2012
Last updated
4 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Seftel MD, Kuruvilla J, Kouroukis T, Banerji V, Fraser G, Crump M, Kumar R, Chalchal HI, Salim M, Laister RC, Crocker S, Gibson SB, Toguchi M, Lyons JF, Xu H, Powers J, Sederias J, Seymour L, Hay AE. The CDK inhibitor AT7519M in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) and mantle cell lymphoma. A Phase II study of the Canadian Cancer Trials Group. Leuk Lymphoma. 2017 Jun;58(6):1358-1365. doi: 10.1080/10428194.2016.1239259. Epub 2016 Oct 17.

    PubMed 27750483

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AT7519M in people with Chronic Lymphocytic Leukemia, run by NCIC Clinical Trials Group at 3 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01627054, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2023.

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